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EUDEMINE Solution for injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Mercury Pharma Group
Διεύθυνση No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
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Name of the medicinal product

Eudemine Injection.

Qualitative and quantitative composition

Neutral glass 20 ml ampoule contains 300mg Diazoxide BP.

Pharmaceutical form

Solution.

Therapeutic indications

Diazoxide is a benzothiadizine analogue. It is used intravenously for the acute treatment of severe hypertension associated with renal disease. Hypertensive emergencies Eudemine injection is used particularly ...

Posology and method of administration

Diazoxide should never be mixed with other drugs and should not be diluted. Hypertensive emergencies ans severe hypertension In the treatment of hypertension, Eudemine injection is administered by the ...

Contraindications

There are no absolute contraindications to Eudemine for the control of hypertension but it should be used with discretion. Agents which can be given by infusion, such as hydralazine or labetalol, should ...

Special warnings and precautions for use

Eudemine injection may cause hyperglycaemia and therefore in the treatment of hypertension, therapy with Eudemine necessitates regular monitoring of the blood glucose levels. Eudemine injection should ...

Interaction with other medicinal products and other forms of interaction

Drugs potentiated by diazoxide therapy include diuretics, anti-hypertensive agents and anticoagulants. Phenytoin may reduce the effects of diazoxide. The risk of hyperglycaemia may be increased by concurrent ...

Pregnancy and lactation

Eudemine injection should only be used in pregnant women when the indicated condition is deemed to be life-threatening to the mother. Eudemine should not be given to nursing mothers as the safety of diazoxide ...

Effects on ability to drive and use machines

None stated.

Undesirable effects

In the treatment of hypertension the hyperglycaemia induced by diazoxide is generally inevitable. Each injection of diazoxide usually means a transient rise in blood sugar of about 10%. Fortunately the ...

Overdose

Excessive dosage of Eudemine injection can result in hyperglycaemia which will respond to insulin and/or to hypotension which will necessitate maintenance of blood volume with intravenous fluids.

Pharmacodynamic properties

Eudemine is a peripheral vasodilator and has qualitatively the same effect on blood vessels as benzothiazine compounds, but the effect is more rapid and profound. Unlike benzothiazines, Eudemine is non-diuretic ...

Pharmacokinetic properties

Eudemine injection is administered to adults as a rapid intravenous injection at doses of 150mg to 300mg initially for the treatment of severe hypertension or hypertensive crises. Approximately 90% of ...

Preclinical safety data

No further data of relevance.

List of excipients

Sodium hydroxide BP Water for injection

Incompatibilities

None stated.

Shelf life

36 months.

Special precautions for storage

Protect from light. Store below 25°C.

Nature and contents of container

20 ml One Point Cut (OPC) clear glass ampoule, Type I Ph.Eur. Borosilicate glass, with white snap ring, in packs of 5, containing 300 mg Diazoxide BP.

Special precautions for disposal and other handling

It is particularly important that Eudemine ampoules are protected from light. Eudemine injection must never be mixed with other drugs, and must not be diluted.

Marketing authorization holder

Mercury Pharma Group Ltd, No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Marketing authorization number(s)

PL 10972/0043

Date of first authorization / renewal of the authorization

22/04/2008

Date of revision of the text

18/09/2012
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